Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311670817279 Date of Approval: 16/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cesarean scar pregnancy: a ten-year single center experience
Official scientific title Cesarean scar pregnancy: a ten-year single center experience
Brief summary describing the background and objectives of the trial Cesarean scar pregnancy (CSP) is a rare but potentially life-threatening form of ectopic pregnancy which incidence has been constantly raising during the last decades. The aim of this study was to describe the epidemiological characteristics of CSP in our population and to investigate the impact of different treatments on the maternal outcomes and prognosis. This was a retrospective study including all patients diagnosed with CSP and who were admitted in our maternity between January 2010 and December 2020. Data were collected from the patients’ medical records. We compared outcomes (hospital stay duration, serum BHCG levels, complications, new pregnancy) in 2 groups: group 1 was treated with systemic injection of methotrexate (MTX) associated with dilatation curettage (DC) and group 2 was managed with uterine artery embolization (UAE) and DC.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Cesarean scar pregnancy
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2010
Actual trial start date 01/01/2010
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 1735
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL bardaaoussema@hotmail.fr
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group intramuscular methotrexate intramuscular methotrexate (MTX) injection (1 mg/kg) 1 day systemic intramuscular methotrexate (MTX) injection (1 mg/kg) associated with ultrasound-guided dilatation curettage and/or laparotomy. 8 Active-Treatment of Control Group
Experimental Group uterine artery embolization uterine artery embolization 1 day uterine artery embolization (UAE) associated with dilatation curettage. 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We included in our study all cases of CSP. The diagnosis of CSP was based on:  A history of previous cesarean deliveries (CD).  Positive -HCG levels in the serum  Ultrasound criteria including: an empty uterine cavity and cervix, an absent or thin myometrium separating the gestational sac and/or placenta from the posterior wall of the bladder, a gestational sac and/or placenta located at the level of the previous uterine scar, and rich trophoblastic blood flow on the Doppler examination. We did not include patients not previously diagnosed with CSP who presented at the emergency room with a complication such as a uterine rupture or uncontrolled hemorrhage. Adult: 19 Year-44 Year 18 Year(s) 43 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/01/2009 MINISTRY OF HEALTH PERSONAL PROTECTION COMMITTEE SOUTH
Ethics Committee Address
Street address City Postal code Country
Institut Pasteur de Tunis , 1002 TUNIS BELVEDERE sfax 3013 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean age was 33.5 years old. Most of patients (80%) reported history of 2 or more previous cesarean sections. The mean gestational age at diagnosis was 8 weeks. Patients presented mostly with isolated amenorrhea. The mean βHCG serum level at admission was 52352.4 milliunits/mL. The diagnosis was made on ultrasonographic examination in all cases. The Management of CSP in group 1 was associated with a significantly shorter resolution time of serum βHCG levels (p=0.006). A shorter hospital stay duration was also reported in group 1 but with no statistical significance (p=0.31). Complications were more observed in group 2 but with no statistical significance (p=0.61). 2 week
Secondary Outcome During the study, a total of 1753 cases of ectopic pregnancies were recorded. Among them, 20 patients diagnosed with CSP were included in the study. The mean age was 33.5 years old ±4.7. The mean gravidity was 4.5(±1.6) and the mean parity was 2.9(±1.5). The mean number of previous cesarean deliveries reported was 2.7(±1.3). Five subjects (25 %) reported undergoing at least one abortion, of which two patients (10%) were treated by dilatation and curettage (DC). CSP was diagnosed in twelve cases (60%) during an early ultrasonographic examination for isolated amenorrhea. Six patients (30%) presented with amenorrhea associated with vaginal bleeding, one patient (5%) with isolated vaginal bleeding and one patient (5%) with lower abdominal pain coupled with amenorrhea. The mean gestational age at diagnosis was 8 weeks (± 2 weeks). At the time of admission, 95 percent of the patients had normal vital signs. One patient (5%), with circulatory collapse, was admitted to the emergency room. Abdominal examination was normal in 95 % of the subjects, one patient (5%) had pelvic tenderness at initial abdominal exam. The gynecological examination showed mild vaginal bleeding in six cases (30%). The mean βHCG serum level at admission was 52352.4 milliunits/mL (5910 milliunits/mL to 151326 milliunits/mL). The mean hemoglobin levels at admission were 11.8 g/dL (±1.5 g/dL). Eight patients (40 %) had anemia at the initial blood count. The CSP diagnosis was made in all patients using the ultrasonography criteria stated above. In terms of management strategies, 40% of patients underwent systemic MTX injection laparotomy, 55% underwent UAE associated with DC, and 5% were managed with systemic MTX associated with UAE and DC. The main complications reported after treatment were uterine rupture (5 %), circulatory collapse (5%) and incomplete uterine rupture (15 %). A transfusion was needed in two cases (10 %). 1 week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
gynecology and obstetrics department hedi chaker sfax Tunisia street ain km0.5 sfax, Tunis Tunisia 3013 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
hedi cheker hospital street ain km0.5 sfax 3013 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor hedi cheker hospital route ain km 0.5 sfax 3013 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bardaa Oussema bardaaoussema@hotmail.fr +21652430325 route ain km 0.5
City Postal code Country Position/Affiliation
sfax 3013 Tunisia resident
Role Name Email Phone Street address
Public Enquiries Oussema bardaa bardaaoussema@hotmail.fr +21652430325 route ain km 0.5
City Postal code Country Position/Affiliation
sfax 3013 Tunisia resident
Role Name Email Phone Street address
Scientific Enquiries Fatma cheker fatmachaker5@gmail.com +21653427934 route ain km 0.5
City Postal code Country Position/Affiliation
sfax 3013 Tunisia assistante
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anyone who wishes to access the data Data are available indefinitely at (Link to be included) Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 month controled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
bardaaoussema@hotmail.fr Yes 03/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information